A Phase 4 interventional study of Stamaril, Sanofi Pasteur and Yellow fever vaccine, Bio-Manguinhos in Yellow Fever, sponsored by Epicentre. Completed at 2 sites in 2 countries. Open to participants aged 9 Months to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Epicentre · Phase 4, Interventional, and Prevention
In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through the African continent and even to Asia, was larger than the available supply. In this situation, the World Health Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever vaccine as a dose-sparing strategy. These recommendations were based on limited number of clinical trials and additional studies should assess the applicability of the fractional dose to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the performance of the fractional dose in young children and populations in Africa including those with HIV.
This study aims to respond to some of the research questions that would allow broadening the recommendations on the use of fractional doses of yellow fever vaccine in emergency situations. The study will be conducted in Uganda and Kenya and the main objective is to assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose compared to full dose for each WHO-prequalified manufacturer. As secondary objectives the study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and persistence of protective antibody levels; describe the geometric mean titre and the change in neutralizing antibody on Day 28 days after vaccination with fractional and full doses; and assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after administration of fractional and full doses.
The study consists of a randomized non-inferiority trial. The study aims to start in April 2017 in the two sites and aims to recruit 960 adults. Results for the main outcome will be reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for the studies in children and HIV positive adults.
Yellow fever (YF) is a mosquito-borne viral disease that is endemic in 34 countries in the African region and 14 in South America. YF virus infection can be asymptomatic or cause a wide spectrum of disease, from mild symptoms to severe, potentially lethal illness with jaundice, renal failure and haemorrhage. The vast majority of reported cases and deaths occur in sub-Saharan Africa where yellow fever is a major health problem occurring in epidemic patterns. There is no specific treatment for yellow fever infection. However, YF vaccine is shown to be very effective for outbreak control as well as for the prevention of outbreaks. YF vaccination confers protection in most vaccinated individuals and this is considered to be life-long.
In 2016, YF outbreaks occurred in Africa (Angola, Democratic Republic of Congo (DRC) and Uganda) as well as in South America (Brazil, Colombia and Peru). Factors such increased urbanization in poor areas without proper water and sanitation systems and population movements, have the potential to contribute to increasing incidence of yellow fever and large epidemics. In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through the African continent and even to Asia, was larger than the available supply. In this situation, the World Health Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever vaccine as a dose-sparing strategy. This strategy consisted on delivering 1/5th of the conventional dose and was used to vaccinate over 7 million people in Kinshasa, the capital city of DRC.
The evidence to recommend the use of fractional dosing was based on a limited number of clinical studies. However this was considered sufficient to provide emergency recommendations. In order to broaden and also possibly simplify WHO recommendations of fractional dose use in case of need for emergency campaigns, additional data is needed to respond to the important data gaps. These include the applicability of the fractional dose to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the performance of the fractional dose in young children and populations in Africa including those with HIV. Following these data gaps, WHO called for research to be conducted.
This study aims to respond to some of the research questions that would allow to broaden the recommendations on the use of fractional doses of yellow fever vaccine in emergency situations. The study will be conducted in Uganda and Kenya and the main objective is to assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose compared to full dose for each manufacturer. As secondary objectives the study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and persistence of protective antibody levels; describe the geometric mean titre and the change in neutralizing antibody on Day 28 after vaccination with fractional and full doses; and assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after administration of fractional and full doses. The study aims to recruit 960 adults (480 in Mbarara, Uganda, and 480 in Kilifi, Kenya). Results for the main outcome will be reviewed by the study Data and Safety Monitoring Board (DSMB) and if results are considered satisfactory, the study will continue with the recruitment of 420 children in Uganda and 250 HIV infected adults in Kenya, to assess non-inferiority of one of the WHO prequalified vaccines.
60 studies on the registry are indexed under Yellow Fever; 12 are open to participants now.
This study's enrollment of 1,630 is above the median of 110 across 48 interventional studies indexed under Yellow Fever.
Browse Yellow Fever studies →Epicentre is the lead sponsor of 47 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subcutaneous administration of 1 dose of a standard yellow fever vaccine
Biological: Stamaril, Sanofi Pasteur
Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
Biological: Stamaril, Sanofi Pasteur
Subcutaneous administration of 1 dose of a standard yellow fever vaccine
Biological: Yellow fever vaccine, Bio-Manguinhos
Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
Biological: Yellow fever vaccine, Bio-Manguinhos
Subcutaneous administration of 1 dose of a standard yellow fever vaccine
Biological: Yellow fever vaccine, Institut Pasteur
Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
Biological: Yellow fever vaccine, Institut Pasteur
Subcutaneous administration of 1 dose of a standard yellow fever vaccine
Biological: Yellow fever vaccine, Chumakov Institute
Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
Biological: Yellow fever vaccine, Chumakov Institute
Subcutaneous administration of 1 dose of the yellow fever vaccine
Biological: Yellow fever vaccine, Chumakov Institute
Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
Biological: Yellow fever vaccine, Chumakov Institute
Subcutaneous administration of 1 dose of the yellow fever vaccine
Biological: Yellow fever vaccine, Chumakov Institute
Subcutaneous administration of 1/5th of a standard dose of yellow fever vaccine
Biological: Yellow fever vaccine, Chumakov Institute
1. Full dose 2. Fractional dose: one fifth (1/5)
1. Full dose 2. Fractional dose: one fifth (1/5)
1. Full dose 2. Fractional dose: one fifth (1/5)
1. Full dose 2. Fractional dose: one fifth (1/5)
1. Full dose 2. Fractional dose: one fifth (1/5)
Also known as: Children sub-study
1. Full dose 2. Fractional dose: one fifth (1/5)
Also known as: HIV + adults
Seroconversion by PRNT50 (Plaque Reduction Neutralization Test 50 value)
Plaque reduction neutralization test will be used to quantify the titer of neutralising antibody for the virus
Time frame: 28 days post-vaccination
Assessment of protection by PRNT50 (Plaque Reduction Neutralization Test 50 value)
Plaque reduction neutralization test will be used to quantify the titer of neutralising antibody for the virus
Time frame: 10 days post-vaccination
Duration of immunity
Assessment of duration of immunity at 1 year after vaccination
Time frame: 1 year post-vaccination
Assessment of adverse events and serious adverse events
Time frame: 28 days post-vaccination
Plan to share: Undecided
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Epicentre